E9-10556. Compliance Policy Guide; “Sec. 110.310 Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002;” Availability

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is announcing the availability of a Compliance Policy Guide (CPG) entitled “Sec. 110.310 Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002.” The CPG provides written guidance to FDA's and Customs and Border Protection's (CBP's) staff on enforcement of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act) and the agency's implementing regulations, which require prior notice for food imported or offered for import into the United States.

DATES:

Submit written or electronic comments concerning the CPG at any time.

ADDRESSES:

Submit written comments on the CPG to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to http://www.regulations.gov. See the SUPPLEMENTARY INFORMATION section for electronic access to the CPG.

Submit written requests for single copies of the CPG to the Division of Compliance Policy (HFC-230), Office of Enforcement, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857. Send two self-addressed adhesive labels to assist that office in processing your request, or fax your request to 240-632-6861.

FOR FURTHER INFORMATION CONTACT:

Laura Draski, Office of Regulatory Affairs (HFC-100), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 866-521-2297.

SUPPLEMENTARY INFORMATION:

I. Background

In the Federal Register of November 7, 2008 (73 FR 66411), FDA announced the availability of a draft CPG entitled “Sec. 110.310 Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002.” After considering the one comment received, FDA revised the CPG, with CBP concurrence, where appropriate. The revised CPG provides written guidance to FDA's and CBP's staff on enforcement of section 307 of the Bioterrorism Act and the agency's implementing regulations, which require prior notice for food imported or offered for import into the United States.

FDA is issuing this CPG as level 1 guidance consistent with FDA's good guidance practices regulation (21 CFR 10.115). The CPG represents the agency's current thinking on its enforcement policy concerning prior notice. It does not create or confer any rights for or on any person and does not operate to bind FDA, or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statutes and regulations.

II. Comments

Interested persons may submit to the Division of Dockets Management (see ADDRESSES) written or electronic comments regarding this document. Submit a single copy of electronic copies or two paper copies of any mailed comments, except that individuals may submit one paper copy. Comments are to be identified with the docket number found in brackets in the heading of this document. The CPG and received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

III. Electronic Access

An electronic version of the CPG is available on the Internet at http://www.fda.gov/​ora under “Compliance References.”

Dated: April 29, 2009.

Michael A. Chappell,

Acting Associate Commissioner for Regulatory Affairs.